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FDA 510(k)

StealthStation S8 System Platforms and StealthStation Cranial Software

K-Number: K162309 · 2017-03-31

ApplicantMedtronic Navigation, Inc.
Decision Date2017-03-31
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

StealthStation S8 System Platforms and StealthStation Cranial Software is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Navigation, Inc.. It received FDA 510(k) clearance on 2017-03-31 under 510(k) number K162309. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the StealthStation S8 System Platforms and StealthStation Cranial Software?

StealthStation S8 System Platforms and StealthStation Cranial Software is a medical device that received FDA 510(k) clearance on 2017-03-31. The listed applicant is Medtronic Navigation, Inc.. The 510(k) number is K162309.

When did StealthStation S8 System Platforms and StealthStation Cranial Software receive FDA 510(k) clearance?

StealthStation S8 System Platforms and StealthStation Cranial Software received FDA 510(k) clearance on 2017-03-31, under 510(k) number K162309.

Who is the listed applicant for StealthStation S8 System Platforms and StealthStation Cranial Software?

The FDA 510(k) record lists Medtronic Navigation, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for StealthStation S8 System Platforms and StealthStation Cranial Software?

The FDA product code for StealthStation S8 System Platforms and StealthStation Cranial Software is HAW.

Other records listing Medtronic Navigation, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253379Stealth AXiS Cranial clinical applicationK253395Stealth AXiS™ ENT clinical applicationK253391Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561)K253381Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical applicationK251282StealthStation S8 Spine SoftwareK242464Stealth™ Spine Clamps; ModuLeX™ Shank Mounts

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Related Devices (Code: HAW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261932Leksell® Vantage Stereotactic SystemElekta Solutions ABK253663Zeta Navigation SystemZeta Surgical, Inc.K253379Stealth AXiS Cranial clinical applicationMedtronic Navigation, Inc.K231897NeuroAlign softwareMedivis, Inc.K251317SOLOPASS 2.0 SystemIntravent Medical PartnersK250893Ball Joint Guide Array (66295)Bayer Medical Care, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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